# K171361: Bettercare Platform - Advanced Web Client

- Pathway: 510(k) (Traditional)
- Applicant: Better Care S.L.
- Decided: Feb 5, 2018 after 272 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K122133 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122133: Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing, Airstrip Technologies, LP (2012) Summary page 5.

## Indications for use
The BetterCare Platform - Advanced Web Client is a software application capable of displaying physiological data and other patient information to clinicians in near real-time through a web browser. The information is captured from patient monitors by the Draeger Infinity Gateway interfaced with the BetterCare Platform and sent through the hospital local area network to wired or wireless devices running the Advanced Web Client application. The information must be analyzed and interpreted by an expert clinician only. The BetterCare Platform is not indicated for use as a real-time monitor. The BetterCare Platform - Advanced Web Client is intended to display data and waveforms from attached medical devices in a pass-though fashion, the BetterCare Platform - Advanced Web Client is agnostic to the age or condition of patients attached to the medical devices from which data is received. For example, the special requirements for neonatal, pediatric or adult patients are all provided by the medical devices directly attached to the patient. The BetterCare Platform - Advanced Web Client simply reproduces that numeric, waveform and other clinical data provided to it for communications and display. The BetterCare Platform - Advanced Web Client is installed on compatible desktop and mobile devices, including cellular telephones, and is intended to be used by clinicians to: - remotely view patient physiological information as captured by Draeger Infinity Gateway - remotely view waveforms as captured by Draeger Infinity Gateway - remotely view other patient data as captured by Draeger Infinity Gateway The BetterCare Platform - Advanced Web Client is not patient connected and is not a primary alarm source. It can display the following physiological data captured by Draeger Infinity Gateway: - ECG Waveform - Arterial Pressure Waveform - SpO2 Waveform - CO2 Waveform - Central Venous Pressure Waveform - Pulmonary Arterial Pressure Waveform - Right Auricular Pressure Waveform - Left Auricualar Pressure Waveform - Resp Waveform - Heart Rate - Respiratory Rate - Oxygen Saturation - Central Venous Pressure - Systolic Arterial Pressure Invasive - Mean Arterial Pressure Invasive - Diastolic Arterial Pressure Invasive - Systolic Blood Pressure Non invasive - Mean Bloood Pressure Non invasive - Diastolic Blood Pressure Non invasive - Systolic Pulmonary Arterial Pressure - Mean Pulmonary Arterial Pressure - Diastolic Pulmonary Arterial Pressure - Right Auricular Pressure - Left Auricular Pressure BetterCare Platform Advanced Web Client is intended to be installed on wired and wireless devices, including cellular telephones, and is not intended to be used where such devices are prohibited. BetterCare Platform Advanced Web Client is intended for use by trained clinicians in hospital environments as a diagnostic aid and not as a replacement for direct viewing of any of the monitoring devices interfaced.

Source page: https://510kreport.com/device/K171361
Methodology: https://510kreport.com/methodology